Home > Biotechnology, Pharmaceuticals & Genetics > Biosimilars (Generic Biotech Drugs) Receive FDA Guidelines for Accelerated Aproval/Competition Will Be Fierce

Biosimilars (Generic Biotech Drugs) Receive FDA Guidelines for Accelerated Aproval/Competition Will Be Fierce, Business and Industry Trends Analysis

The Biologics Price Competition and Innovation Act of 2009 provided FDA guidelines for generic biotech drugs, which are called “biosimilars” or “follow-on biologics.”  The Act establishes standards for FDA approval of biosimilars and details ways of handling patent disputes.  The Act also grants 12 years of intellectual property protection to biologic drugs, which would significantly extend the life of branded biotech-based drugs.  This exclusivity would protect the original maker of a biologic, because a generic competitor would not be able to utilize data from the clinical trials conducted by the original maker until the 12 years had passed and the…

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